Zoladex PBS exit delayed as AstraZeneca weighs next steps in breast cancer

AstraZeneca will extend access to its Zoladex monthly (3.6mg) implant via the Pharmaceutical Benefits Scheme (PBS) until 1 May 2027, pushing back the previously scheduled 1 November 2026 delisting by six months.

The extension follows the recent PBS listing of Diphereline (triptorelin 3.75mg) as an alternative to Zoladex 3.6mg, despite the treatment not having undergone Therapeutic Goods Administration (TGA) regulatory approval for a breast cancer indication.

The initial decision to delist Zoladex prompted significant concerns that more than 7,500 women with breast cancer could be left without an alternative treatment.

Dr Marie Guillet, Country President, AstraZeneca Australia and New Zealand, said “We recognise the significant concern felt by patients and we are pleased to confirm today that access to the Zoladex monthly (3.6mg) implant will extend on the PBS, with eligible patients being able to fill their PBS script for another 18 months.”

AstraZeneca had initially pursued a price increase for the Zoladex monthly (3.6mg) implant as a means of preserving its PBS listing. However, the Pharmaceutical Benefits Advisory Committee (PBAC) did not support a price adjustment.

“Zoladex monthly (3.6mg) has decades of clinical use in Australia and around the world. It is, however, expensive to manufacture and the accumulation of years of inflation has increased the manufacturing cost, despite productivity improvements. On the other hand, the price is less than half what it was when first listed in 1991,” Dr Guillet said.

AstraZeneca said it will now consider submitting a further application for a pricing increase to secure long-term reimbursed access for the Zoladex monthly (3.6mg) implant. Its previously announced continuity program will not proceed, with PBS prescriptions written by 30 April 2027 remaining eligible for dispensing until 1 May 2028.

“Universal and equitable access to medicines is critical to the continued health of Australians. The PBS will require appropriate funding to ensure Australians are not denied access to medicines,” Dr Guillet added.

Meanwhile, the higher-dose Zoladex three-monthly (10.8mg) implant, which has been previously indicated for prostate cancer, is now registered by the TGA for the management of oestrogen-receptor (ER) positive early and advanced breast cancer in pre and peri menopausal women.

AstraZeneca is awaiting the outcome of the PBAC’s evaluation of its submission seeking PBS listing of the expanded indication for this patient cohort.

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